Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The SoundScar Study The SOUNDSCAR Study (SoundScar)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03862339
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
Papworth Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Liverpool Heart and Chest Hospital NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Prospective, Non-randomized, Single-arm Study to assess the accuracy of intracardiac echocardiography (ICE) for characterization of arrhythmogenic substrate in patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation

Condition or disease
Ventricular Tachycardia Ischemic Cardiomyopathy

Detailed Description:
ICE imaging during VT ablation is currently largely used for definition of cardiac anatomy. The role of the technique to specifically define scar and arrhythmogenic substrate has not been systematically evaluated. The aim is to assess the efficacy of the technique to accurately define the arrhythmogenic substrate.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging [ Time Frame: 1 week ]
    Area with abnormal contraction as correlated the findings on voltage mapping (low voltage) of the left ventricle in patients with a prior myocardial infarction undergoing VT ablation.


Secondary Outcome Measures :
  1. Areas of abnormal contraction as determined by ICE imaging [ Time Frame: 1 week ]
    Area of abnormal contraction correlating with the findings on voltage mapping (local abnormal ventricular activities) of the left ventricle in patients with a prior myocardial infarction undergoing VT ablation


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation
Criteria

Inclusion Criteria:

  • Prior heart attack (myocardial infarction) with evidence from prior non-invasive imaging demonstrating regions of the heart with reduced heart muscle function (myocardial hypokinesia/akinesia/thinning) in the absence of a non-heart attack-related (non-ischaemic) cause
  • Age over 18 years
  • One of the following abnormal heart rhythm (VT) events within last 6 months:
  • ≥3 episodes of VT treated with therapeutic rapid pacing from an implantable cardiac defibrillator (antitachycardia pacing [ATP])
  • ≥1 appropriate shocks from an implantable cardiac defibrillator
  • ≥3 episodes of abnormal heart rhythm (VT) within 24 hours
  • Sustained VT below the detection rate of the implantable cardiac defibrillator (documented by ECG/cardiac monitor)
  • Sustained abnormal heart rhythm (VT) in the absence of ICD which is documented by ECG/cardiac monitor
  • Patients in whom ICE imaging is planned for the clinical VT ablation procedure (clinical indication)

Exclusion Criteria:

  • Patient unable or unwilling to provide informed consent.
  • Acute heart attack (acute coronary syndrome with acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of abnormal heart rhythm (VT) - e.g. electrolyte abnormalities or drug-induced abnormal heart rhythms
  • Ineligible for ablation (known to have protruding clot in the chamber of interest (left ventricular thrombus), or have implanted mechanical aortic and mitral valves)
  • Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)
  • Pregnant patients (pregnancy test will be performed in patients who are of childbearing age who are not on an effective contraceptive prior to all VT ablation procedures)
  • Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862339


Contacts
Layout table for location contacts
Contact: Michael Noorzadeh 01516001242 Michael.Noorzadeh@lhch.nhs.uk

Locations
Layout table for location information
Australia, New South Wales
Westmead Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Timothy Campbell, BSc    +61426731727    timothy.campbell@sydney.edu.au   
Contact: Mary Wong, PhD    +61426731727    mary.s.wong@sydney.edu.au   
Principal Investigator: Saurabh Kumar, MD, PhD         
United Kingdom
Liverpool Heart and Chest Hospital NHS Trust Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Michael Noorzadeh       Michael.Noorzadeh@lhch.nhs.uk   
Sponsors and Collaborators
Liverpool Heart and Chest Hospital NHS Foundation Trust
Papworth Hospital NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Saagar Mahida, MD Liverpool Heart and Chest Hospital
Principal Investigator: Sharad Agarwal, MD Papworth Hospital NHS Trust
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03862339    
Other Study ID Numbers: 1171
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:
Catheter Ablation
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathies
Tachycardia
Tachycardia, Ventricular
Heart Diseases
 Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes